Resonacle as an Officer – DRA (Clinical) (ROW). The company is inviting applications from candidates with B.Pharm, M.Pharm, or Life Sciences backgrounds who have 1–3 years of experience in Clinical DRA for ROW markets.
This pharmaceutical regulatory affairs opportunity is ideal for professionals experienced in clinical regulatory submissions, CTD/eCTD documentation, dossier preparation, and regulatory compliance. The position offers a 5-day working schedule and the opportunity to work in a dynamic regulatory environment handling global submissions.
Job Highlights
- Company: Resonacle
- Job Role: Officer – DRA (Clinical) (ROW)
- Location: Mumbai, Maharashtra
- Work Schedule: 5 Days Working
- Department: Clinical Regulatory Affairs
- Experience Required: 1–3 Years
- Qualification: B.Pharm, M.Pharm, or Life Sciences
- Employment Type: Full-Time
Key Responsibilities
The selected candidate will be responsible for:
- Preparing and reviewing clinical regulatory dossiers for ROW markets.
- Managing regulatory submissions, variations, renewals, and agency responses.
- Coordinating with cross-functional teams to ensure timely regulatory submissions.
- Ensuring compliance with global regulatory guidelines and requirements.
- Maintaining high-quality regulatory documentation.
- Supporting lifecycle management activities for clinical products.
Eligibility Criteria
Candidates should possess:
- B.Pharm, M.Pharm, or a degree in Life Sciences.
- 1–3 years of experience in Clinical DRA (ROW).
- Working knowledge of CTD/eCTD documentation.
- Good understanding of international regulatory requirements.
- Strong communication, documentation, and coordination skills.
Preferred Skills
- Clinical Regulatory Affairs
- ROW Regulatory Submissions
- CTD & eCTD Documentation
- Dossier Preparation
- Regulatory Compliance
- Variation & Renewal Filing
- Cross-functional Coordination
- Pharmaceutical Documentation
Why Join Resonacle?
- 5-day work week
- Exposure to international regulatory submissions
- Opportunity to work with global regulatory standards
- Career growth in Clinical Regulatory Affairs
- Collaborative and professional work environment
How to Apply
Interested and eligible candidates can share their updated CV at:
Email: saniya.shaikh@resonacle.com